Dermatological composition

ABSTRACT

Dermatological compositions containing a humectant, e.g., at least one of urea, ammonium lactate, and glycerin, and an emollient, e.g., at least one of Shea or cocoa butter, glycine soja sterol and hybrid sunflower oil. The compositions of the invention may be utilized for treatment or amelioration of skin disorders or adverse physiological conditions, and such compositions may be employed as a base for cosmetic or pharmaceutical formulations for dermal administration.

RELATED APPLICATION DATA

This application is a continuation of U.S. application Ser. No.10/723,777, filed Nov. 26, 2003, the entire contents of which isincorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The present invention relates to dermatological compositions useful asskin protectants, or alternatively as a base composition for use incosmetic applications or in formulations for therapeutic application ofpharmaceutical agents to the body via topical administration.

BACKGROUND OF THE INVENTION

In the field of dermatological compositions, a wide variety offormulations have been developed and commercialized. Such compositionsinclude cosmetic formulations, skin care formulations and pharmaceuticalformulations for topical administration of therapeutic agents to treator prevent disease states and adverse physiological conditions.

Many such dermatological compositions have been formulated withpreservatives such as parabens and other organic chemical compounds.Generally, it is advantageous to formulate dermatological compositionsthat are free of such preservatives or that otherwise minimize theamounts of such preservatives.

Concurrently, there is a progressive movement toward dermatologicalcompositions having natural product ingredients, consistent with thegoals of achieving enhanced biocompatibility, under the impetus ofincreasing environmental awareness, and avoiding adverse reactions thatmay occur in the use of dermatological compositions employingpetroleum-based or other synthetic product ingredients.

Dermatological compositions frequently are formulated with humectantingredients of widely varying types. Urea is a beneficial humectant,which has the additional advantages of keratolytic activity, and athigher concentrations the ability to solublize and denature proteins andthe ability to exert mild antibacterial effects. Ammonium lactate isanother humectant ingredient having desirable properties indermatological compositions.

It would be a significant advance in the art to provide improveddermatological compositions that avoid high concentrations oftraditional petroleum-derived formulation ingredients, that are free ofconventional preservatives, that utilize natural product ingredients,and that are broadly useful for cosmetic, skin-care and pharmaceuticalapplications.

SUMMARY OF THE INVENTION

The present invention relates to dermatological compositions havingutility for cosmetic, skin-care and/or pharmaceutical applications.

In one aspect, the present invention relates to a dermatologicalcomposition comprising a humectant including at least one of urea,ammonium lactate, and glycerin, and at least one emollient selected fromthe group consisting of Butyrospernum Parkii (Shea butter) fruit,glycine soja (soybean) sterol and Helianthus Annuus (hybrid sunflower)oil.

In another aspect, the invention relates to a dermatological compositionincluding urea, and at least one of (i) Shea butter, (ii) glycine soja(soybean) sterol and (iii) Helianthus Annuus (hybrid sunflower) oil.

In another aspect, the invention relates to a dermatological compositioncontaining ammonium lactate, in combination with at least one of Sheabutter, glycine soja (soybean) sterol and Helianthus Annuus (hybridsunflower) oil.

In a further aspect, the invention relates to dermatologicalcompositions including from about 1 to about 50 percent by weight ofurea, from about 2 to about 10 percent by weight Shea butter, from about1 to about 4 percent by weight glycine soja (soybean) sterol, from about2 to about 15 percent by weight Helianthus Annuus (hybrid sunflower)oil, with the balance being dermatologically acceptable excipients. Inspecific embodiments, such compositions may have a urea concentration offrom about 5 to about 40 percent by weight, or alternatively aconcentration of from about 20 to about 40 percent by weight, e.g., fromabout 21 percent by weight to about 40 percent by weight.

As used herein, references to compositional ingredients in percents byweight refers to weight percentages based on the total weight of thecomposition or formulation.

Compositions of the above-described types can also include from about 2to about 10 percent by weight of emulsifier(s), such as glycerylstearate and/or a dermatologically acceptable stearate derivative and/orstearic acid, or a dermatologically acceptable salt thereof. Thecompositions can also include from about 0.1 to about 1.5 percent byweight of a thickener, such as sodium polyacrylate or xanthan gum. Thecompositions can further include a pH adjusting agent such astriethanolamine, and/or a chelating agent such as EDTA ordermatologically acceptable salts thereof.

The various compositions of the invention may be in the form of lotions,creams, emulsions, suspensions, ointments, gels or other suitable formscapable of administration to the skin of a user. Accordingly,compositions in which water and/or water-miscible solvents are employedin varying amounts, are contemplated. Additionally, the compositions maybe formulated with adjuvants, additional active ingredients and/orexcipients, and/or other ingredients, to impart specific thixotropy,viscosity, flow, spreading, self-leveling, or other characteristicsthereto, as necessary or desirable in specific formulations.

In another aspect, the invention relates to a composition including:

-   -   (a) from about 1 to about 50 percent by weight urea;    -   (b) from about 2 to about 10 percent by weight Shea butter;    -   (c) from about 1 to about 4 percent by weight glycine soja        (soybean) sterol;    -   (d) from about 2 to about 15 percent by weight of Helinthus        annuus (hybrid sunflower) oil;    -   (e) from about 2 to about 10 percent by weight of an emulsifier;    -   (f) from about 0.1 to about 1.5 percent by weight of a        thickener; and    -   (g) optionally, a pH adjusting agent, a chelating agent, an        antioxidant, a preservative, water or a combination of water and        a water-miscible solvent or other dermatologically acceptable        components (e.g., other non-water soluble components), and/or        mixtures thereof;        with the percentages by weight of all ingredients totaling to        100 weight percent.

In yet another aspect, the invention relates to a composition including:

-   -   (a) from about 2 to about 15 percent ammonium lactate;    -   (b) from about 2 and 10 percent by weight Shea butter;    -   (c) from about 1 and 4 percent by weight glycine soja (soybean)        sterol;    -   (d) from about 2 to about 15 percent by weight of Helinthus        annuus (hybrid sunflower) oil;    -   (e) from about 2 to about 10 percent by weight of an emulsifier;    -   (f) from about 0.1 to about 1.5 percent by weight of a        thickener; and    -   (g) optionally, a pH adjusting agent, a chelating agent, a        preservative, an antioxidant, a preservative, water or a        combination of water and a water-miscible solvent or other        dermatologically acceptable components (e.g., other non-water        soluble components), and/or mixtures thereof;        with the percentages by weight of all ingredients totaling to        100 weight percent.

BHT is an example of a suitable antioxidant, EDTA (and salts thereof) isan example of a suitable chelating agent, sodium polyacrylate is anexample of a suitable thickener, and triethanolamine is an example of asuitable pH adjusting agent.

A further aspect of the invention relates to a dermatologicalcomposition comprising a humectant including at least one of urea,ammonium lactate and glycerin, and an emollient including at least oneof: (i) Shea butter, cocoa butter, or vegetable oil butter; (ii)plant-derived steroid alcohol and/or lecithin; and (iii)oxidation-stable natural oil.

In another aspect, the invention relates to a composition as variouslydescribed hereinabove, in combination with one or more additionalcomponents. Such additional components may include active and/orinactive (inert) ingredients. Additional components may include any ofvarious botanical extracts, singly or in combination, that are includedto impart specific beneficial attributes to the skin, tissue and/ornails. Examples of additional active components include enzymes such aspapain to promote skin debriding, anti-microbials, anti-fungals (e.g.,for treating fungal infections of the toenails or fingernails) andanti-inflammatory agents, particularly non-steroidal anti-inflammatoryagents such as glucocorticosteroids.

A still further aspect of the invention relates to a method of treatingskin, tissue and/or nails, involving applying to the skin, tissue and/ornails a composition as variously described hereinabove.

The compositions of the invention can be variously formulated and can beused, for example, to treat a wide variety of disorders of the skin,tissue and nails, such as psoriasis, ichthyosis, xerosis, keratosis,keratoderma, dermatitis, pruritis, eczema, calluses, and ingrownfingernails and/or toenails. The compositions can also be used todebride and/or soften the skin.

Other aspects, features and embodiments of the invention will be morefully apparent from the ensuing disclosure and appended claims.

DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS THEREOF

The dermatological compositions of the invention may be formulated inany suitable form for topical administration, including lotions, creams,emulsions, suspensions, ointments, gels, etc., depending on the specificcombination and relative proportions of ingredients, including forexample the amount of water and/or other solvents in the composition,and the amounts of any corresponding thickeners, fixatives, rheologicalagents, surface active agents, etc., as employed to provide a desiredsolid, semi-solid, liquid, or other form for application to the skin.Specific formulations can be made within the skill of the art, based onthe disclosure herein, to yield appropriate compositions that areabsorbable into the stratum corneum or otherwise administrable witheffect to the skin.

The compositions of the invention may be formulated in variant manners,utilizing urea, ammonium lactate and/or glycerin as humectantcomponents. As used herein, the term “ammonium lactate” is used broadlyto refer to ammonium lactate per se, as well as to mixtures of ammoniumlactate and lactic acid (and/or other alpha-hydroxy acids such asglycolic, malic, citric, etc.).

In urea-containing compositions of the invention, urea may be utilizedin combination with at least one of Shea butter, glycine soja (soybean)sterol and Helianthus Annuus (hybrid sunflower) oil.

Set out in Table 1 below is a listing of potential ingredients,potential ranges and alternative species for selected components, inaccordance with one aspect of the invention. In Table 1, the compositioncan further comprise water and/or other dermatologically compatibleexcipients in appropriate amounts for a given application.

TABLE 1 Concentration Range, Component Weight % Alternative ComponentsUrea  1%-50% ammonium lactate; glycerin; various combinations of thesemain and alternative components Butylated Hydroxytoluene 0.05%-0.5% butylated hydroxyl anisol, ascorbyl palmitate, propyl gallate,alpha-tocopherol, citric acid, ascorbic acid, tocopherol acetate(tocopherols and derivatives thereof), grapeseed extract (Vitisvinifera), green tea extract (Camellia sinensis), retinyl palmitate,diacetyl methyl silicone Butyrospermum Parkii (Shea 0.5%-10%  cocoabutter, vegetable jojoba Butter) Fruit esters, cera alba (Beeswax),jojoba oil (Simmondsia Chinensis), castor oil, PEG 1500, PEG 400, andmodified vegetable oil “butters,” mango butters Disodium EDTA0.05%-0.3%  pentasodium DTPA, tetrasodium EDTA, furildioxime GlycerylStearate  2.0%-10.0% polysorbate 60, glycol palmitate, glycol laurate,cetyl alcohol, soy lecithin, ceteareth-20 Glycine Soja (Soybean) Sterol1.0%-4.0% plant-derived steroid alcohols (e.g., sitosterol,stigmasterol, campesterol, brassicasterol, lanosterol,7-dehydrocholesterol) and/or lecithin Helianthus Annuus (Hybrid2.0%-15%  oxidation-stable natural oils, e.g., Sunflower) Oil oilobtained from plants such as rapeseed (Brassica spp.), soybean (Glycinemax), oil palm (Elaeis guineeis), coconut (Cocus nucifera), castor(Ricinus communis), safflower (Carthamus tinctorius), mustard (Brassicaspp. and Sinapis alba), coriander (Coriandrum sativum) linseed/flax(Linum usitatissimum), thale cress (Arabidopsis thaliana) and maize (Zeamays) Sodium Polyacrylate 0.1%-1.5% other thickeners orthickening/emulsifying/ stabilizing additives, e.g., methyl cellulose,PEG-150 distearate, lecthin, cetearyl alcohol, carbomer, acryliccopolymers, polyacrylamides, beeswax, magnesium aluminum silicate,hydrogenated castor oil, xanthum gum, behenyl alcohol, stearyl alcohol,PEG 4000, PEG 6000, polyoxyethylene distearate, glycerylpolymethacrylate Stearic Acid 3.0%-8.0% other fatty acid emulsifiers,e.g., lauric acid, myristic acid Triethanolamine 0.25%-2.5%  other pHadjusting agents, e.g., basic pH adjusting agents such as sodiumhydroxide, ammonium hydroxide, potassium hydroxide, monethanolamine,diethanolamine, diisopropanolamine, aminomethylpropanol, tromethamine,tetrahydroxypropyl ethylenediamine

Compositions in accordance with Table 1 can be variously formulated,wherein the weight percentages of all ingredients total to 100 weightpercent.

The compositions of the invention can be formulated with pH adjustingagents to impart any suitable pH characteristic to the specificdermatological composition, e.g., a substantially neutral pH. Inspecific embodiments, it may be desirable to formulate the compositionas having an initial pH in a range of from about 4 to about 10, or in arange of from about 7 to about 10, or in a range of from about 7.5 toabout 9.0, depending on the specific utilization of the composition.

In other specific compositions, time-release pH adjustment agents may beemployed, to counteract the tendency of urea to produce ammonia,resulting in progressively increasing pH of the composition, duringextended storage or use of the composition.

Compositions of Table 1 may be formed with water or mixtures of waterand water-miscible solvent(s). Examples of water-miscible solventsinclude alcohols and glycols. The relative proportions of water or waterand water-miscible solvents(s) in specific compositions of the inventionmay be widely varied. For example, compositions may include creamformulations having a low relative amount of water, in comparison tolotions or emulsions having a higher relative proportion of water.

Concerning the reasons for the specific concentration ranges ofingredients set out in Table 1, such ranges have been determined toprovide dermatological compositions of superior character, relative tocompositions having ingredients outside of such concentration ranges.Nonetheless, it will be understood that compositions of the inventionmay be widely varied, to include relatively higher or lowerconcentrations than those set out in Table 1, or to include differentnumbers and types of ingredients therein, in specific embodiments.

In general, the amount of urea in urea-containing compositions of theinvention should be at least 1% to provide a desired substantialhumectant effect. Amounts of urea typically do not exceed above 50weight percent, in order to provide optimal dermatologicalcompatibility. In particular embodiments, the amount of urea may bepreferably in a range of from about 5 to about 41 percent, morepreferably in a range of from about 10 to about 40 percent, and mostpreferably in a range of from about 20 to about 40 percent.

The amounts of Shea butter, glycine soja sterol and hybrid sunflower oilare advantageously utilized in the amounts identified in Table 1, inorder to provide a desired level of emolliency in the composition. Theamounts of other components such as antioxidants, chelants, emulsifiers,thickeners and/or pH adjusting agents may be varied in respect ofparticular relative proportions that achieve the specific functionalcharacteristics for which such ingredients are utilized in thecomposition.

Ammonium lactate-containing compositions of the invention may beformulated with ammonium lactate in amounts appropriate to thedermatological application of the composition, in combination with atleast one of Shea butter, glycine soja sterol and hybrid sunflower oil.In specific embodiments, the ammonium lactate may be present in amountsof from about 1 to about 15 weight percent, more specifically from about2 to about 12 weight percent, and most specifically from about 5 toabout 12 weight percent. In a further specific embodiment, an ammoniumlactate-containing composition may be formulated at 12% lactic acidcontent, and partially neutralized with ammonium hydroxide, e.g., at aconcentration of 1.75% of formula weight, to obtain a specific desiredpH.

Table 2 below sets out ingredients, concentrations and potentialequivalents for illustrative ammonium lactate-containing compositions inspecific embodiments of the invention.

TABLE 2 Concentration Range, Component Weight % Alternative ComponentsAmmonium lactate/lactic acid  1%-15% other alpha-hydroxyl acids (e.g.,glycolic, malic, citric, etc.) Butylated Hydroxytoluene 0.05%-0.5% Other antioxidants, e.g., butylated hydroxyl anisol Butyrospermum Parkii(Shea 0.5%-10%  Cocoa butter, vegetable jojoba Butter) Fruit estersDisodium EDTA 0.05%-0.3%  Other chelants Glyceryl Stearate  2.0%-10.0%Other emulsifiers, e.g., stearates Glycine Soja (Soybean) Sterol1.0%-4.0% Plant-derived steroid alcohols Helianthus Annuus (Hybrid2.0%-15%  Oxidation-stable natural oils Sunflower) Oil SodiumPolyacrylate 0.1%-1.5% Other thickeners or thickening/emulsifying/stabilizing additives, e.g., methyl cellulose Stearic Acid3.0%-8.0% Other fatty acid emulsifiers Triethanolamine 0.25%-2.5%  OtherpH adjusting agents, e.g., basic pH adjusting agents such as sodiumhydroxide, ammonium hydroxide, etc.

The reasons for the specific ranges of ingredients that are identifiedin Table 2 are analogous to those discussed hereinabove in connectionwith Table 1 urea-containing compositions of the invention.

Dermatological compositions of the invention may be utilized fortreatment of a wide variety of dermal conditions and adversephysiological states manifesting dermally, including, withoutlimitation, dry skin/xerosis, psoriasis, ichthoyosis, keratosis,keratoderma, dermatitis, pruritis, eczema, callouses, and ingrown nails.Compositions of the invention are usefully employed as skinmoisturizers, skin softening agents, skin debridement agents, etc., aswell as base composition for cosmetic formulations, as well as basecompositions for therapeutic, e.g., pharmacological, formulations. Incosmetic formulations, the compositions of the invention may be usedwith added ingredients that are solely cosmetic. Alternatively, thecosmetic formulation may include ingredients that are both cosmeticallyefficacious and therapeutically effective, e.g., so-called“cosmeceutical” ingredients.

In therapeutic formulations, the compositions of the invention may beutilized as base compositions for topical administration of therapeuticagents such as wound healing agents, anti-inflammatory agents, e.g.,non-steroidal anti-inflammatory agents, glucocorticosteroids (e.g.,hydrocortisone, triamcinolone, betametamethasone, or their respectivederivatives, or ibupropfen, ketoprofen, methyl salicylate, etc.),anti-infective (antibiotic) agents (e.g., bacitracin, polymixin B,mupirocin, neomycin, and mixtures thereof), enzymes, anti-fungal agents,anti-viral agents, acne-combating agents, rosacea-combating agents,dermatitis-combating agents, topical immunomodulator agents, etc., aswell as any other agents that are beneficially applied to the skin totreat or ameliorate symptoms of physiological disorders and diseasestates susceptible to such treatment or amelioration.

Set out below in Table 3 is a tabulation of therapeutic agents bycategory and specific examples, and associated indications (diseasestates or adverse physiological conditions or symptoms) for whichdermatological compositions of the invention may be utilized intherapeutic formulations. In the use of such therapeutic agents, thecomposition of the invention as variously described hereinabove,comprising humectant, emollients and optional additional excipients, isutilized as a base to which the therapeutic agent is added in atherapeutically effective amount to yield a corresponding therapeuticcomposition for combating the appertaining disease state or adversephysiological condition constituting the specific indication.

TABLE 3 Possible Indications for Active Ingredient Category ActiveIngredient Examples Active Ingredient Wound Healing papain, trypsin,allantoin, chymo- skin debridement agent, trypsin, streptokinase,accelerator for wound healing streptodornase, ficin, pepsin,carboxypeptidase, amino- peptidase, chymopapain, bromelinAnti-Inflammatory hydrocortisone, triamcinolone, reducer of redness,itching and betametamethasone, swelling, contact dermititis ibupropfen,ketoprofen, methyl salicylate, dexamethasone, prednisolone, cortisone,prednisone, beclomethasone, betamethasone, flunisolide, fluocinoloneacetonide, fluocinonide, indomethacin, diclofenac sodium, mefenamicacid, azulene, phenacetin, isopropylantipyrine, acetaminophen, bendzac,phenylbutazone, flufenamic acid, sodium salicylate, salicylamide,sasapyrine, etodolac Anti-Infectives bacitracin, polymixin B, topicalbacterial infections, mupirocin, neomycin, impetigo, folliculitis,carbuncles tetracyclines (chlortetracycline hydrochloride,oxytetracycline hydrochloride and tetracycline hydrochoride),clindamycin, gentamicin sulfate, benzalkonium chloride, benzethoniumchloride, hexylresorcinol, methylbenzethonium chloride, phenolAnti-Fungals miconazole, econazole, tinea pedis, tinea capitis, tineatolnaftate, ketoconazole, cruris, tinea corporis, tinea undecylenicacid, amphotericin versicolor, topical candidiasis B, carbol-fuchsin,ciclopirox, clotrimzole, haloprogin, mafenide, naftifine, nystatin,oxiconazole, silver, sulfadiazine, sulconazole, terbinafine,tioconazole, undecylenic acid Anti-Acne salicylic acid, benzoylperoxide, Acne, rosacea, seborheic resorcinol, sulfur, dermatitis sodiumsulfacetamide, retinoic acid, isotretinoin, erythromycin, zinc, retinol,citric acid, and alpha hydroxy acid Anti-Virals acyclovir, docosanol,Topical treatment of HSV-1, pencyclovir, cidofovir, HSV-2,Vericella-Zoster desciclovir, famciclovir, ganciclovir, lobucavir, PMEA,valacyclovir, 2242, PAA, PFA, H2G, sorivudine, trifluridin,tromantadine, adenine, arabinoside, arabinosyladenine- monophosphate,lobucavir Topical Immunomodulators pimecrolimus, tacrolimus, atopicdermatitis muramyl dipeptide, cyclosporins, interferons (includingalpha, beta, and gamma interferons), interleukin-2, cytokines, tumornecrosis factor, pentostatin, thymopentin, transforming factor β₂,erythropoetin

In like manner, the compositions of the invention may be employed incosmetic applications, by addition thereto of a cosmetically effectiveamount of a cosmetic agent, e.g., in the form of a pigment, powder,microencapsulated particulate, etc., together with adjuvants,excipients, and the like that are appropriate to such application of thecomposition.

More generally, dermatological compositions of the invention may beformulated with a wide variety of excipients, including emulsifiers andthickeners, as are conventionally employed in skin care products and inspecific forms (creams, lotions, emulsions, suspensions, ointments,gels, etc.).

Examples of dermatologically acceptable excipients include, withoutlimitation, emulsifiers, thickeners, pH adjusting agents, chelatingagents, and preservatives.

Emulsifiers include, for example, C₁₆₋₁₈ straight or branched chainfatty alcohols or fatty acids or mixtures thereof, such as cetylalcohol, stearyl alcohol, stearic acid, palmitic acid, and mixturesthereof. Glyceryl stearate is another suitable emulsifier, which is alsoavailable commercially as a self-emulsifying grade of glycerol stearate(i.e., glycerol stearate SE, which typically contains some sodium and/orpotassium stearate).

Thickeners include compounds like sodium polyacrylate and xanthan gum.Xanthan gum is a high molecular weight heteropolysaccharide gum producedby pure-culture fermentation of a carbohydrate with Xanthomonascampestris. Another suitable thickener is a mixture of a carbomer andtriethanolamine. The carbomers come in various molecular weights andidentified by numbers. These are commercially known as Carbopols.Carbopols are homopolymers of acrylic acid crosslinked with an allylether of pentaerythritol, an allyl ether of sucrose or an allyl ether ofpropylene. Carbomers can be used as thickeners, and also help to suspendand stabilize the emulsion. Illustrative Carbopols include Carbopol 940,carbomer 910, 2984, 5984, 954, 980, 981, 941 and 934, Carbopol ETD 2001,2020, and 2050 and Ultrez 20. The mixture is combined together and addedto the composition in an amount totaling anywhere from about 0.05 toabout 30 wt-%.

Still other thickeners that may be usefully employed in particularcompositions of the invention include methyl cellulose, polyethyleneglycol species such as PEG-150, PEG 4000 and PEG 6000, distearate,lecthin, cetearyl alcohol, acrylic copolymers, polyacrylamides, beeswax,magnesium aluminum silicate, hydrogenated castor oil, behenyl alcohol,stearyl alcohol, polyoxyethylene distearate, glyceryl polymethacrylate,and the like.

Butylated hydroxy toluene (BHT) and analogs thereof, and various othercomponents may be employed as stabilizers for the composition. VariouspH-adjusting agents may be employed in compositions of the invention,including, by way of example, hydroxide salts (i.e., calcium hydroxide,sodium hydroxide, potassium hydroxide) and amines, such astriethanolamine. Triethanolamine (also known as Trolamine) is apreferred pH-adjusting agent.

Dermatological compositions of the present invention may be readilyformulated in any suitable manner. In one embodiment, the composition isprepared by mixing the humectant, such as urea, ammonium lactate and/orglycerin, with an appropriate amount of water or water-miscible solventmixture for the composition. The mixing operation may be carried out attemperature in a range of from ambient (room temperature) to elevatedtemperature of 85-95° C. The mixing may be carried out utilizing aCowles mixer or other suitable mixing device, e.g., a sonicator, paddlemixer, helical static mixer apparatus, or the like. The water preferablyis pre-purified to appropriate purity for the composition. Mixing iscarried out for sufficient duration to fully solublize the humectantcomponent in the aqueous medium. Concurrently, the remaining ingredientsare separately mixed by addition mixing of such components, and suchmixing may be carried out at suitable temperature, e.g., in a range offrom about ambient (room temperature) to 85-95° C., for sufficientduration to homogenize the mixture of ingredients. The respectivevolumes of ingredients then are consolidated under mixing conditions atsuitable temperature, e.g., in a range of from about ambient (roomtemperature) to about 75-80° C., followed by cooling (if the compositionis at elevated initial temperature) to ambient temperature followed bypackaging of the product into suitable containers for storage, transportand ultimate use.

Alternatively, all of the other ingredients of the composition may beadded simultaneously or sequential or in other order to water or to awater and water-miscible solvent mixture, under agitation or othermixing conditions, to homogenize the material and produce a compositionof the desired consistency in the specific product form (e.g., lotion,cream, gel, suspension, emulsion, etc.).

The features and advantages of the invention are more fully apparentfrom the following non-limiting examples, wherein all parts andpercentages are by weight, unless otherwise expressly stated.

EXAMPLE 1

A dermatological lotion composition in accordance with the invention wasformulated, including the following ingredients and concentrations, asidentified in Table 4 below.

TABLE 4 Ingredient Percentage by Weight Urea 40 Water 39.10 DisodiumEDTA 0.10 Sodium polyacrylate 0.60 Stearic Acid 4.0 Glyceryl stearate3.0 Soy Sterol 2.0 Sunflower oil 8.0 Shea Butter 2.0 Triethanolamine 1.0BHT 0.2

The composition was formulated by mixing of the respective ingredientsto provide a homogeneous lotion. The lotion was tested by application todermal surfaces and confirmed as being of appropriate character for skinmoisturizer use.

EXAMPLE 2

A dermatological cream composition in accordance with the invention wasformulated, including the following ingredients at the specifiedconcentrations, as identified in Table 5 below.

TABLE 5 Ingredient Percentage by Weight Urea 40 Water 36.7 Disodium EDTA0.10 Sodium polyacrylate 1.0 Stearic Acid 4.0 Glyceryl stearate 3.0 SoySterol 2.0 Sunflower oil 10.0 Shea Butter 2.0 Triethanolamine 1.0 BHT0.2

The cream was formulated by mixing of the respective ingredients toprovide a semi-solid cream. The cream was tested by application todermal surfaces and confirmed as being of appropriate character for skinmoisturizer use.

Although the invention has been described herein with respect tospecific aspects, features and embodiments, it will be recognized thatthe invention is susceptible to application with other variations,modifications and alternative embodiments. Accordingly, the invention isintended to be broadly construed and interpreted, as encompassing allsuch variations, modifications and alternative embodiments within thespirit and scope of the invention as hereafter claimed.

1. A dermatological composition, comprising the following components inthe following respective concentration ranges: Concentration Range,Component Weight % Urea  1%-50% Butylated Hydroxytoluene 0.05%-0.5% Butyrospermum Parkii (Shea 0.5%-10%  Butter) Fruit Disodium EDTA0.05%-0.3%  Glyceryl Stearate  2.0%-10.0% Glycine Soja (Soybean) Sterol1.0%-4.0% Helianthus Annuus (Hybrid 2.0%-15%  Sunflower) Oil SodiumPolyacrylate 0.1%-1.5% Stearic Acid 3.0%-8.0% Triethanolamine0.25%-2.5% 

wherein weight % is based on the total weight of the composition and theweight percentages of all components in the composition totals 100%. 2.A dermatological composition according to claim 1, wherein theconcentration of urea is in a range of from about 5 to about 40 weight%.
 3. A dermatological composition according to claim 1, wherein theconcentration of urea is in a range of from about 21 to about 40 weight%.
 4. A dermatological composition according to claim 1, furthercomprising water.
 5. A dermatological composition according to claim 1,wherein the composition is an aqueous formulation comprising thefollowing components in the following respective concentrations:Component Weight % Urea 40.0% Butylated Hydroxytoluene 0.2%Butyrospermum Parkii (Shea 2.0% Butter) Fruit Disodium EDTA 0.1%Glyceryl Stearate 3.0% Glycine Soja (Soybean) Sterol 2.0% HelianthusAnnuus (Hybrid 8.0% Sunflower) Oil Sodium Polyacrylate 0.6% Stearic Acid4.0% Triethanolamine 1.0%


6. The composition of claim 5, in the form of a suspension.
 7. Adermatological composition according to claim 1, wherein the compositionis an aqueous formulation comprising the following components in thefollowing respective concentrations: Component Weight % Urea 40.0%Butylated Hydroxytoluene 0.2% Butyrospermum Parkii (Shea 2.0% Butter)Fruit Disodium EDTA 0.1% Glyceryl Stearate 3.0% Glycine Soja (Soybean)Sterol 2.0% Helianthus Annuus (Hybrid 10.0% Sunflower) Oil SodiumPolyacrylate 1.0% Stearic Acid 4.0% Triethanolamine 1.0%


8. The composition of claim 7, in the form of an emulsion.
 9. A methodof treating skin, tissue or nails, comprising application thereto of acomposition as claimed in claim
 1. 10. The method of claim 9, comprisingcosmetic treatment.
 11. The method of claim 9, comprising debridingskin, softening tissue, or softening nails.
 12. The method of claim 9,comprising therapeutic treatment.
 13. The method of claim 9, comprisingtreating skin for a condition selected from the group consisting ofpsoriasis, xerosis, ichthoyosis, keratosis, keratoderma, dermatitis,pruritis, eczema, and calluses.
 14. A dermatological composition,comprising the following components: Urea, Glycerin, ButyrospermumParkii (Shea Butter) Fruit, Helianthus Annuus (Hybrid Sunflower) Oil andat least one additive selected from the group consisting ofantioxidants, chelants, emulsifiers, thickeners, and pH adjustmentagents.
 15. The dermatological composition of claim 14, wherein the atleast one additive comprises wax, polyacrylamide, paraffin, lauric acid,laureth, disodium EDTA, and butylated hydroxytoluene.
 16. Thedermatological composition of claim 14, further comprising water. 17.The dermatological composition of claim 14, comprising Urea, Glycerin,Butyrospermum Parkii (Shea Butter) Fruit, Helianthus Annuus (HybridSunflower) Oil, wax, polyacrylamide, paraffin, laureth, disodium EDTA,BHT, and water.
 18. The dermatological composition of claim 14,comprising the following components in the following respectiveconcentration ranges: Concentration Range, Component Weight % Urea,glycerin  1%-50% Butylated Hydroxytoluene 0.05%-0.5%  ButyrospermumParkii (Shea 0.5%-10%  Butter) Fruit, wax Disodium EDTA 0.05%-0.3% Helianthus Annuus (Hybrid 2.0%-15%  Sunflower) Oil Sodium Polyacrylate,0.1%-1.5% polyacrylamides, wax, paraffins Lauric Acid 3.0%-8.0%

and further comprising water, wherein weight % is based on the totalweight of the composition and the weight percentages of all componentsin the composition totals 100%.
 19. The dermatological composition ofclaim 18, wherein the concentration of urea is 40%.
 20. Thedermatological composition of claim 14, in a form selected from thegroup consisting of lotions, creams, ointments, emulsions, suspensionsand gels.